FDA 510(k) Application Details - K982216

Device Classification Name	Monitor, Breathing Frequency   More FDA Info for this Device
510(K) Number	K982216
Device Name	Monitor, Breathing Frequency
Applicant	BRAEBON MEDICAL CORP. 63 ACKLAM TERRACE KANATA K2K 2H7 CA Other 510(k) Applications for this Company
Contact	RICHARD A BONATO Other 510(k) Applications for this Contact
Regulation Number	868.2375   More FDA Info for this Regulation Number
Classification Product Code	BZQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/23/1998
Decision Date	09/11/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review